The Lachman Blog

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10
Jun

New Requirements on FDA Notification of Suspected Illegitimate Products To Begin January 1, 2015

FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of FDA by trading partners of the potential suspect products. The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion. The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.

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06
Jun

DMFs in the Spotlight at the GPhA/FDA CMC Workshop

In the first two years of GDUFA, the Office of Generic Drugs (OGD) DMF review team has been hard at work clearing up the backlog of DMF reviews and trying to figure out how to stay ahead of the game once the GDUFA metrics kick in in 2015. OGD did not want to penalize GDUFA submissions based on DMF submissions too severely because the DMF review process was so dramatically impacted and adjusted once GDUFA went into effect. So for years 1 and 2 of GDUFA, OGD exercised some regulatory flexibility in establishing a workable system. Now OGD has some advice for ANDA applicants that must be incorporated into your development and submission plans before your application is submitted.

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04
Jun

Good News on Supplement Backlog Outlined at GPhA/FDA CMC Workshop

The Office of Generic Drugs (OGD) is now receiving help from other CDER components in its battle to get the supplement backlog down. In May of 2013, OGD reported just fewer than 6000 supplements in its backlog. Today with a little help from their friends, the total supplemental backlog stands at less than 4000. What we don’t know is how many of the actions that took the supplements off of the OGD clock were Complete Response letters versus approvals.

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03
Jun

Use of Animal Rule Discussed in Revised FDA Guidance

FDA typically requires safety and efficacy to be demonstrated in humans, but there are times when exposure of humans to toxic therapeutic substances may be impractical and ethically impossible (e.g., antidote for nerve gas treatment, nuclear threat, biological, chemical or substance that would otherwise causea life-threating condition or poisoning [e.g., snake venom, virus, industrial chemicals]). The FDA has released a newly revised update to its previously issued 2009 Guidance on this topic.

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02
Jun

April OGD Statistics Just Published – Let’s Look at the Numbers a Bit Differently

Usually I concentrate on ANDAs received and the numbers approved as a measure of the Office of Generic Drugs’ (OGD) progress, but this month, let’s just mention that there were 41 full approvals and 7 tentative Approvals and, as the table below reveals, OGD received 74 ANDAs in April 2014. By the way, OGD reported issuing 100 Complete Response Letters in April 2014.

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28
May

Buyer Beware! That Legitimate Looking Prescription Site May Cost You Your Health

In a coordinated enforcement action involving the FDA, US Customs and Border Patrol, along with international agencies like Interpol and enforcement and regulatory bodies from 111 countries, action was taken against web sites that “sell unapproved prescription drugs to US consumers.” This is part of an ongoing effort of a program termed Operation Pangea.

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28
May

Salonpas Pain Relief Patch Petition Does Not Provide Full Relief Sought by Petitioner

In a petition response issued on May 23, 2014to Hisamitsu Pharmaceutical Company, the FDA partially approved, but mostly denied the requests of the NDA holder for Salonpas (menthol and methyl salicylate 3%, 10%) Patch in a petition submitted on January 6, 2010. While the response did not come as much of a surprise relative to the NDA holders asks, the fact that the petition was submitted in 2010 and is just now being responded to is somewhat a matter of conjecture.

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